What are the responsibilities and job description for the Senior Quality Engineer | QA Engineer | GMP | CAPA | ISO 9001 | Pharmaceutical Manufacturing | Onsite NJ position at Tranzeal Incorporated?
Tranzeal is an industry leading global Business Transformation Service Provider offering specific consulting services as well as prepackaged, industry specific solutions and services to companies around the world. Our Consulting Services are dedicated to helping our clients maximize their investments in IT and the overall effectiveness and efficiency of the business. Tranzeal s deep industry experience makes us the partner of choice for a growing number of Fortune 1000 companies, midsize enterprises and small businesses worldwide.
We are currently looking for 'Senior Quality Engineer | QA Engineer | GMP | CAPA | ISO 9001 | Pharmaceutical Manufacturing | Onsite NJ' to support one of our clients with the following skills:
Requirement:
Job Title: Senior Quality Engineer / Quality Assurance Engineer
(Senior Quality Engineer | QA Engineer | GMP | CAPA | ISO 9001 | Pharmaceutical Manufacturing | Onsite NJ)
Job Type: Contract (W2 Only)
Location: Phillipsburg, NJ (100% Onsite)
Duration: 18 Months
Rate: DOE
Work Schedule: Monday – Friday | 8:00 AM – 5:00 PM (Flexible)
Job Summary
We are seeking an experienced Senior Quality Engineer / Quality Assurance Engineer to support quality systems, regulatory compliance, audits, investigations, CAPA management, and continuous improvement initiatives within a GMP-regulated manufacturing environment.
The ideal candidate will have a strong background in Pharmaceutical, Biotechnology, Chemical, or Life Sciences manufacturing and hands-on experience working in cGMP and ISO-regulated environments.
Required Qualifications
- Bachelor's Degree in Chemistry, Biology, Chemical Engineering, Biochemistry, Microbiology, or related scientific discipline
- Minimum 5 years of Quality Assurance / Quality Engineering experience
- Experience working in Pharmaceutical, Biotechnology, Chemical, or Life Sciences manufacturing environments
- Strong experience with GMP investigations and deviation management
- Hands-on experience with CAPA (Corrective and Preventive Actions)
- Root Cause Analysis experience
- Customer Complaint Investigation and Resolution experience
- Internal and External Audit experience
- Experience supporting Change Control processes
- Validation support and process improvement experience
- Working knowledge of cGMP, FDA regulations, ISO 9001, and ICH guidelines
- Strong analytical, problem-solving, documentation, and communication skills
Key Responsibilities
- Lead Quality Management System (QMS) initiatives and continuous improvement projects
- Manage CAPA programs and ensure effective implementation of corrective actions
- Conduct and support GMP investigations and complaint investigations
- Lead internal, customer, supplier, and regulatory audits
- Ensure compliance with cGMP, FDA, ISO, and applicable regulatory requirements
- Support validation activities, change controls, and process improvements
- Analyze quality trends and prepare quality metrics and reports
- Deliver GMP/GDP training and support quality compliance programs
- Collaborate with Operations, Quality, R&D, Procurement, and Commercial teams to resolve quality-related issues
Preferred Industry Experience
- Pharmaceutical Manufacturing
- Biotechnology Manufacturing
- Chemical Manufacturing
- Reagents / Life Sciences
- Medical Device Manufacturing
Mandatory Skills
Quality Assurance, Quality Engineering, GMP Investigations, cGMP, CAPA, Root Cause Analysis, Customer Complaint Investigations, Internal Audits, Regulatory Compliance, ISO 9001, FDA Regulations, Change Control, Validation Support, Pharmaceutical Manufacturing, Biotechnology Manufacturing, Chemical Manufacturing, Quality Management Systems (QMS)
If you meet the above qualifications and are interested in this opportunity, please send your updated resume to:
sureshs@tranzeal.com